- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
FDA Approves Perjeta (Pertuzumab) for Neoadjuvant Breast Cancer Treatment
First drug approved for use in preoperative breast cancer (September 30)
The FDA has granted accelerated approval to Perjeta (pertuzumab, Genentech) as part of a complete treatment regimen for patients with early-stage breast cancer before surgery (neoadjuvant setting). Perjeta is the first FDA-approved drug for the neoadjuvant treatment of breast cancer.
Perjeta (pertuzumab) was approved in 2012 for the treatment of patients with advanced or late-stage (metastatic) HER2-positive breast cancer.
With the new approval, Perjeta can now be used for patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer (tumor greater than 2 cm in diameter or with positive lymph nodes) who are at high risk of metastasis or of dying from the disease. The drug is to be used in combination with trastuzumab and other chemotherapy prior to surgery and, depending on the treatment regimen used, may be followed by chemotherapy after surgery. Following surgery, patients should continue to receive trastuzumab to complete 1 year of treatment.
The FDA’s approval for neoadjuvant treatment is based on a study that was designed to measure the pathologic complete response (pCR), defined as the absence of invasive cancer in the breast and lymph nodes. In the study, 417 participants were randomly assigned to receive one of four neoadjuvant treatment regimens: trastuzumab plus docetaxel, pertuzumab plus trastuzumab and docetaxel, pertuzumab plus trastuzumab, or pertuzumab plus docetaxel. Approximately 39% of participants who received pertuzumab plus trastuzumab and docetaxel achieved pCR, compared with about 21% of those who received trastuzumab plus docetaxel.
Source: FDA; September 30, 2013.